Accelerated Clinical Trial Process Image: Long Description

Overview

The accelerated clinical trial process graphic provides an overview of the activation process. The graphic outlines the  completion of the activation process within 65 calendar days. It also outlines the 45 day process leading up to the start of the activation process.

Presentation

Pre-work timeline (45 days):

• PI/OCT: CDA Receipt and Finalization
• Study Team: Site Feasibility Survey
• Study Team: Pre-Site Visit
• PI/Study Team: Notify OCT Project Manager ACT Process Start

Accelerated clinical trials process (65 days):

• Contract path: 
  • OCT/Ancillary: Contract Review
  • OCT/Sponsor: Contract Negotiation
  • OCT/Sponsor: Contract Finalization
  • OCT/Sponsor: Contract Signatures
• Budget path:
  • OCT: Per Patient Cost Analysis Completion
  • Study Team: Cost Analysis Review
  • OCT/Study Team: Billing Code Review
  • OCT/Sponsor: Budget Negotiation
  • OCT/Sponsor: Budget Finalization
  • OCT/Sponsor: Contract Signatures
• Regulatory path:
  • Study Team: External IRB Application Submission
  • Study Team: External IRB Approval Letter
  • Study Team: UMMC IRB Application
  • HRO: UMMC Administrative Review
  • Ancillary Committees: Perform Reviews
  • HRO: UMMC Approval to Start Letter
  • OCT/Sponsor: Budget Finalization
  • OCT/Sponsor: Contract Signatures

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